ReGelTec Inc receives FDA breakthrough device designation for hydrogel injection
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ReGelTec Inc. announced it has received breakthrough device designation from the FDA for its Hydrafil system for the treatment of degenerative disc disease and chronic low back pain.
A hydrogel that is heated prior to injection into the nucleus of a degenerated disc, the Hydrafil system forms a contiguous implant to augment the disc, restore the biomechanical properties of the spinal segment and alleviate pain, according to a company press release. The release noted ReGelTec Inc. has completed procedures in 20 patients as part of an ongoing early feasibility study in Barranquilla, Colombia, with indications of significant pain relief and reduction of disability at 30- and 90-day follow-up visits. The company also announced it has raised $4 million for its Series A financing to support the ongoing clinical and development work of this system.
“I am happy that the FDA has recognized the potential of Hydrafil to treat one of the most prevalent, debilitating and costly conditions that I see in my practice in patients with chronic low back pain and degenerative disc disease,” Douglas Beall, MD, chair of the medical advisory board for ReGelTec Inc., said in the release. “This designation will allow us to more rapidly move clinical work to the U.S. and expand our clinical trials, building on the promising results of the early feasibility study.”
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